Millions of diabetics are force to draw blood daily to determine their blood sugar levels. To alleviate the constant discomfort of these individuals, substantial effort has been expanded in the search for a non-invasive apparatus and methodology to accurately determine blood glucose levels. Four patent applications, each assigned to Optiscan Biomedical Corporation of Alameda, Calif., have significantly advanced the state of the art of non-invasive blood glucose analysis The methodology taught in U.S. patent application Ser. No. 08/820,378 is performed by the apparatus taught in U.S. patent application Ser. No. 08/816,723, and each of these references is herewith incorporated by reference. While the methodology taught in the incorporated references presents a significant advance in non-invasive glucose metrology, there exists room for further improvements. One such improvement lies in the manner in which the data collected by the apparatus are manipulated. In the methodology taught in Ser. No. 08/820,378 a volts-to-watts radiometric calibration step is often required. To preclude this requirement, U.S. patent application Ser. No. 09/267,121 teaches a methodology that takes advantage of the fact that by inducing a temperature gradient, a difference parameter between the signal at a reference wavelength and the signal of an analyte absorption wavelength may be detected. The frequency or magnitude or phase difference of this parameter may be used to determine analyte concentration. A further object of the invention taught therein is to provide a method of inducing intermittent temperature modulation and using the frequency, magnitude, or phase differences caused by analyte absorbance to determine analyte concentration. This intermittent temperature may be periodic or a periodic. Another improvement concerns U.S. patent application Ser. No. 09/265,195 entitled: "Solid-state Non-invasive Infrared Absorption Spectrometer for the Generation and Capture of Thermal Gradient Spectra from Living Tissue" which teaches a method of inducing a temperature gradient and monitoring of radiation emitted from test samples. The complete teachings of U.S. patent application Ser. No. 09/267,121 and Ser. No. 09/265,195 are also herewith incorporated by reference.
As has been noted in Ser. No. 09/265,195, the non-invasive spectrometer require calibration to assure quality performance to the diabetic end user. While such calibration presents no particular difficulty in the laboratory environment, it will be appreciated that accurate calibration in the field presents some rather interesting challenges. The laboratory type standards are basically an aqueous solution of glucose, where the exact concentration of glucose is known. However, once this type of prior art standard solution leaves the laboratory it is subject to a wide variety of environment effects which can serve to degrade its accuracy. Such effects include, but are not limited to evaporation, contamination, fermentation, dilution, sundry photochemical effects, spillage, and the like. Given the need for extremely precise measurements afforded by the principles of the present invention, any degradation in accuracy is unacceptable. A further second problem lies in the fact that a prior art solution of glucose cannot properly mimic the physiology of human tissue. To applicants' knowledge there are no known standards available for use in calibrating a non-invasive spectrometer in the field that can overcome the foregoing problems associated with laboratory standards comprising aqueous solution of glucose.
Thus, a primary object of the present invention is to provide a calibration standard apparatus for use in calibrating a non-invasive spectrometer in the field.
A related object of the present invention is to provide a field calibration standard that overcomes the problems associated with prior art laboratory type of standards comprising aqueous solution of glucose.
An other object of the present invention is to provide a field calibration standard that properly mimic the physiology of human tissue.
Yet another object of the present invention is to provide a spectrometer apparatus that not only can perform non-invasive glucose level tests in humans, but that is adapted to receive the calibration standards and perform the thermal gradient calibration measurements.